Monoferric

Monoferric Uses, Dosage, Side Effects, Food Interaction and all others data.

Iron deficiency is an extremely common condition and is the most frequent cause of anemia worldwide. Iron deficiency results when iron intake, iron stores, and loss of iron from the body do not adequately support production of erythrocytes, also known as red blood cells. Though it is generally considered non life-threatening, iron deficiency may considerably affect quality of life.

Monoferric is a form of iron used in the treatment of iron deficiency. This drug is a complex of iron (III) hydroxide and derisomaltose. The latter is an iron carbohydrate oligosaccharide that works to release iron. Monoferric was developed by Pharmacosmos Therapeutics ad was granted FDA approval in January 2020. Clinical trials show that it is non-inferior to iron sucrose, another form of iron that is often administered in iron deficiency, and less likely to cause serious hypersensitivity that is associated with other forms of injectable iron.

Ferric derisomaltase increases the reticulocyte count and ultimately increases hemoglobin, treating iron deficiency anemia and its various symptoms. Parenteral iron, such as ferric derisomaltose, may cause false elevations in serum bilirubin levels and falsely reduced serum calcium.

Trade Name Monoferric
Generic Ferric derisomaltose
Ferric derisomaltose Other Names Ferric derisomaltose
Weight 100mg/ml,
Type Intravenous solution
Formula C18H34FeO16
Weight Average: 562.297
Monoisotopic: 562.117975
Protein binding

Iron binds to transferrin, the transport molecule responsible for transporting iron to erythroid precursor cells for the production of hemoglobin.

Groups Approved
Therapeutic Class
Manufacturer
Available Country United States
Last Updated: September 19, 2023 at 7:00 am
Monoferric
Monoferric

Uses

Monoferric is an iron injection used in the treatment of iron deficiency anemia.

This drug is indicated for the treatment of iron deficiency anemia in adult patients who have experienced intolerance to oral iron preparations or insufficient clinical response to orally administered iron. Ferric derisomaltase is also indicated for patients with non-hemodialysis dependent chronic kidney disease. In Australia and United Kingdom, ferric derisomaltase is indicated for cases in which rapid delivery of iron is required.

Monoferric is also used to associated treatment for these conditions: Iron Deficiency Anemia (IDA), Requirement for rapid iron delivery

How Monoferric works

This drug is a complex made of iron (III) hydroxide and derisomaltose, which is an iron carbohydrate oligosaccharide that works to releases iron. The released iron then binds to the transport protein, transferrin, and is taken to erythroid precursor cells for incorporation into the hemoglobin molecule.

Toxicity

LD50 information for ferric derisomaltose is not readily available in the literature, however, the LD50 for iron sucrose (another form of intravenous iron) was 140 mg/kg in male rats. An overdose with ferric derisomaltose may lead to accumulation of stored iron, causing hemosiderosis. Symptoms may include abdominal pain, weakness, and lethargy, among others. Serum ferritin should be monitored. Employ supportive treatment including chelating agents.

Food Interaction

No interactions found.

Volume of Distribution

Monoferric or released iron that was released is found in cells of the reticuloendothelial system (RES). It is found to be highly concentrated in the liver and spleen. The volume of distribution of other forms of intravenous iron is 3L, on average, in a 70 kg adult. Though the specific volume of distribution of ferric derisomaltose is not readily available in the literature, it is likely similar to other intravenous forms of iron.

Elimination Route

After a single 1000 mg dose, the Cmax and AUC of serum iron were 408 μg/mL and 17730 μg.h /mL, respectively. Serum ferritin concentrations reach their peak about 7 days after a single dose of intravenous ferric derisomaltose.

A note on concomitant oral iron

The absorption of oral iron is decreased when administered with intravenous iron. The administration of oral iron should be delayed until at least 5 days after the last ferric derisomaltose injection.

Half Life

The plasma-half live of intravenous iron is about 1-4 days.

Clearance

Intravenous iron is cleared from the plasma. Monoferric is not eliminated via the kidneys, as the size of the complex is large and cannot be excreted via the nephron.

Elimination Route

Renal elimination was not a significant route of elimination in single-dose pharmacokinetic studies. Iron can often accumulate in the body leading to iron overload followed by toxic effects. Small amounts of ferric derisomaltose are excreted in the urine and feces.

Innovators Monograph

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